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Effect of Air-stacking on Peak Cough Flow in Patients With Acute Cervical or High Thoracic Spinal Cord Injury

NCT ID: NCT01046175

Last Updated: 2010-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-06-30

Brief Summary

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Respiratory complications continue to be one of the leading causes of morbidity and mortality in people with spinal cord injury, especially among cervical and higher thoracic injuries. Both inspiratory and expiratory function are often severely decreased, leading to respiratory complications, such as atelectasis, pneumonia and ventilatory failure. The prevention of these respiratory complications needs to begin immediately after injury. To achieve effective expelling of secretions before they form mucus plugs, it is essential to improve patients ability to cough. Manually assisting the cough is one way of increasing cough flow, but an effective cough also requires adequate lung volumes. The emphasis should therefore be on expansion of the lungs before coughing. One way of expanding the lungs is by air-stacking. In air-stacking insufflations are stacked in the lungs to maximally expand them. Cough can be valued by measuring Peak Cough Flow (PCF). By combining air-stacking with manually assisted cough the PCF can be increased sufficiently. The aim of this study is to compare the effect of two different air-stacking techniques on PCF, air-stacking on a respirator versus air-stacking with a manual resuscitator.

Detailed Description

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Conditions

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Spinal Cord Injury Tetraplegia

Keywords

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Respiratory complications respiratory insufficiency respiratory therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Airstacking with manual resuscitator

Air-stacking is a type of lung volume recruitment technique where insufflations are stacked in the lungs to maximally expand them, here done with a manual resuscitator.

Group Type EXPERIMENTAL

Air-stacking with a manual resuscitator

Intervention Type PROCEDURE

Stacking air into the lungs up to maximal insufflation capacity (MIC)with a manual resuscitator

Air-stacking with ventilator

Air-stacking is a type of lung volume recruitment technique where insufflations are stacked in the lungs to maximally expand them, here done with a ventilator.

Group Type ACTIVE_COMPARATOR

Air-stacking with ventilator

Intervention Type PROCEDURE

Stacking air into the lungs to maximal insufflation capacity (MIC) with ventilator

Interventions

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Air-stacking with a manual resuscitator

Stacking air into the lungs up to maximal insufflation capacity (MIC)with a manual resuscitator

Intervention Type PROCEDURE

Air-stacking with ventilator

Stacking air into the lungs to maximal insufflation capacity (MIC) with ventilator

Intervention Type PROCEDURE

Other Intervention Names

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Lung volume recruitment technique Lung volume recruitment technique

Eligibility Criteria

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Inclusion Criteria

* acute cervical or high thoracic spinal cord injury admitted to the ICU

Exclusion Criteria

* substantial abdominal or thoracic injury
* substantial brain damage
* intubated or tracheostomized patients
* not able to cooperate
* pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ullevaal University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Oslo University Hospital, Ullevaal, Dept. of Phys. Med & Rehab.

Principal Investigators

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Helene L Soberg, PhD

Role: STUDY_CHAIR

Oslo University Hospital

Locations

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Oslo University Hospital, Ullevaal

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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S-09326b

Identifier Type: -

Identifier Source: org_study_id